A European Multicenter Open-label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

(a) The patient is willing to provide written informed consent to participate in this study.
(b) The patient is at least 18 years of age.
(c) The patient can be either an out-patient or an in-patient.
(d) The patient has a histologically documented diagnosis of cancer (i.e., a solid tumor or hematological malignancy).
(e) The patient has stable background pain due to cancer.
(f) The patient experiences, on average, up to 4 BTP episodes per 24 hours occurring at the location of the chronic pain, while taking maintenance opioid therapy.
(g) As maintenance opioid therapy the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.
(h) Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
(i) The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, complete the diaries, and attend scheduled study visits as specified in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(a) The patient is without maintenance opioid therapy, as there is an increased risk of respiratory depression.
(b) The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the maintenance opioid therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
(c) The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.
(d) The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.
(e) The patient has a medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
(f) The patient is expected to have surgery during the study.
(g) The patient is pregnant or lactating.
(h) The patient has participated in a study involving an investigational drug in the prior 30 days.
(i) The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
(j) The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient’s safety or compliance with the study protocol, or compromise collected data.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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